Analgesic Effect of Acupuncture for Patients With Rib Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03822273|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rib Fractures Acute Pain Analgesia||Procedure: Traditional acupuncture (TA) Procedure: Laser acupuncture (LA) Procedure: Sham laser acupuncture (SLA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||All the patients are told that they will receive one kind of acupuncture treatment in addition to the original oral analgesics and assess the efficacy of acupuncture. The patients are randomly assigned to three groups after providing written informed consent, without being mentioned which kind of acupuncture treatment is applied as control. Patients are not blinded to TA or LA treatment, but they can be blinded to LA or SLA treatment. The outcome assessor is also blinded to the group assignments and is trained to apply the pain scales and conduct physical tests. To avoid unblinding of the assessment of outcomes, the patients are instructed not to discuss any aspect related to their treatment with the assessor.|
|Official Title:||Analgesic Effect of Acupuncture for Patients With Rib Fractures: an Open-label, Randomized-controlled Trial|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Traditional acupuncture (TA)
The subject will receive real acupuncture treatment once per day for 3 days after enrollment.
Procedure: Traditional acupuncture (TA)
Procedure: real acupuncture.
Eight disposable, single use, sterilized, stainless steel needles are inserted at each session, and the bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for acupuncture treatment. The acupuncture needles are to be inserted to a depth of 15-35 mm. All needles are rotated manually at least once at each session to elicit needle sensation (De qi). The needle retention time is 15 min.
Active Comparator: Laser acupuncture (LA)
The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.
Procedure: Laser acupuncture (LA)
Procedure: laser acupuncture.
Participants allocated to the LA group receive laser acupuncture treatment at the same acupoints used in acupuncture group. The laser acupuncture therapy will be performed with the gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz]; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser will be applied to each point for 5 seconds, which delivered 0.375 J of energy at each of the acupoints: LI4 (Hegu, B3), SJ6 (Zhigou, B3), ST36 (Zusanli, B2) and GB34 (Yanglingquan, B2).
Placebo Comparator: Sham laser acupuncture (SLA)
The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.
Procedure: Sham laser acupuncture (SLA)
Procedure: sham laser acupuncture.
Subjects in the control group receive sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the LA group.
- Efficacy of pain relief [ Time Frame: The NRS will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. Primary outcome is the change of NRS score on DAY 1 pretreatment and DAY 3 post treatment. ]Maximal pain intensity (Numerical Rating Scale; NRS: 0‑10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed.
- Sustained maximal inspiration lung volumes [ Time Frame: The sustained maximal inspiration lung volumes will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. ]Sustained maximal inspiration lung volumes
- Number of cases with pulmonary complications [ Time Frame: Follow-up for one month ]Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.
- Saliva cortisol level [ Time Frame: The saliva cortisol level will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. ]Saliva cortisol level
- Heart rate variation [ Time Frame: The heart rate variation will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. ]Heart rate variation
- The dose of narcotic and non-narcotic analgesics used [ Time Frame: Record the medication use for 2 weeks after participant enrolled ]Record the use of narcotic and non narcotic analgesics based on chart reviews. Narcotic drugs include codeine, tramadol, and morphine. Non narcotic drugs include acetaminophen, ibuprofen, diclofenac, ketoprofen, mefenamic acid, and parecoxib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822273
|Contact: Chun-Ting Liu, MD||+886-7-7317123 ext firstname.lastname@example.org|
|Kaohsiung Chang Gung Memorial Hospital||Recruiting|
|Kaohsiung, Taiwan, 833|
|Contact: Chun-Ting Liu, MD +886-7-7317123 ext 2334 email@example.com|
|Principal Investigator:||Chun-Ting Liu, MD||Chang Gung Memorial Hospital|